This application for an institutional National Research Service Award (T32) in Pediatric Clinical and Developmental Pharmacology requests support for a new postdoctoral training program that will train the next generation of pediatric clinical investigators to assume leadership roles in developing innovative, high impact clinical and developmental pharmacology related approaches that will improve proper use of medicines in children to enhance pediatric therapeutics and related health outcomes of children. Many medicines used in children have not been scientifically evaluated for use in the pediatric population and are either used unlicensed or in an off-label manner. In addition, few medicines are developed specifically to treat childhood diseases. The Pediatric Clinical and Developmental Pharmacology Research Training Program (PCDP-RTP) at Cincinnati Children's Hospital Medical Center (CCHMC) is designed specifically to address this critical need. The program is based in the Division of Pediatric Clinical Pharmacology, which is jointly a unit within the Department of Pediatrics and in the University of Cincinnati, College of Medicine. This T32 Pediatric Clinical and Developmental Pharmacology Research Training Program also involves strong collaborations with the James L. Winkle College of Pharmacy and the Departments of Pharmacology & Cell Biophysics and Mathematical Sciences at the University of Cincinnati. Faculty advisors for the PCDP-RTP come from 12 divisions within the Department of Pediatrics and four Departments at the University of Cincinnati. Faculty have expertise in an array of fields relevant to clinical, translational and basic science research of pediatric disease areas that include adherence, bioinformatics, biomarker development, biostatistics and epidemiology, comparative effectiveness, clinical outcomes, clinical trials, epidemiology, genetics/genomics and gene expression, clinical and developmental pharmacology, quality improvement, and systems biology/pharmacology. The T32 training program is innovative and well aligned with the objectives outlined in the program announcement because: 1) it has a focus in early and later phase studies in multiple and diverse pediatric populations through ongoing research collaborations with all major pediatric subspecialties; 2) involves the application and development of innovative quantitative methodologies such as physiologically based PK/PD modeling and simulation and disease progression analysis through our multidisciplinary Pharmacometrics Core; 3) is embedded in the institutional and Academic Health Center's pharmacogenetic/genomics research endeavors through the Personalized Medicine and Genetic Pharmacology Programs; 4) is closely integrated with biostatistics and epidemiology, bio-informatics, and health services and outcomes research; 5) can rely on over ten years of experience as one of 13 sites of the NICHD Pediatric Pharmacology Research Unit Network. The typical period of support for trainees will be two years, though an additional period of support may be provided, especially if it will make them more competitive for subsequently establishing an independent research career. The PCDP-RTP is well supported by core facilities and a variety of academic programs at the University of Cincinnati's Academic Health Center, which includes CCHMC, UCCOM, the James L. Winkle College of Pharmacy and several other allied colleges. We believe that the PCDP-RTP provides a unique resource that will open an important new avenue to enlarge the pool of talented young clinical investigators with a career interest in pediatric therapeutics. The proposed training program will allow them to acquire a refined vision for applying state of the art principles of clinical and developmental pharmacology to sound clinical research and evidence-based clinical practice to improve pediatric health outcomes. PUBLIC HEALTH RELEVANCE: The T32 Pediatric Clinical and Developmental Research Training Program will provide an outstanding resource for expanding and improving the current critically small pool of pediatric clinical pharmacologists by training the next generation of pediatric clinical investigators to assume leadership roles in developing innovative, high impact clinical and developmental pharmacology related approaches that will improve proper use of medicines in children. This will allow the further enhancement of personalized pediatric therapeutics and ultimately improve the quality of care and related health outcomes of children.